{"id":1516,"date":"2023-11-15T22:27:02","date_gmt":"2023-11-15T22:27:02","guid":{"rendered":"https:\/\/economicherald.net\/?p=1516"},"modified":"2023-11-15T22:27:02","modified_gmt":"2023-11-15T22:27:02","slug":"us-fda-grants-argenica-orphan-drug-designation-to-treat-devastating-condition-in-newborns","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=1516","title":{"rendered":"US FDA grants Argenica Orphan Drug designation to treat \u2018devastating condition\u2019 in newborns"},"content":{"rendered":"<p>US FDA grants ARG-007 orphan drug designation to treat hypoxic ischaemic encephalopathy<br \/>\nNo therapeutic drug on the market to protect brain cells following hypoxic ischaemic encephalopathy<br \/>\nPre-clinical studies have shown promising results of ARG-007 in treating the condition<\/p>\n<p>\u00a0<\/p>\n<p><strong><em>Special Report:<\/em><\/strong> <strong>Argenica Therapeutics has achieved a key milestone, with the US Food and Drug Administration <\/strong><strong>(FDA) granting orphan drug designation (ODD) for ARG-007 for the treatment of hypoxic ischaemic encephalopathy (HIE).<\/strong><\/p>\n<p>Perth-based\u00a0<a href=\"https:\/\/stockhead.com.au\/company\/argenica-therapeutics-agn\/\"><strong>Argenica Therapeutics (ASX: AGN)<\/strong><\/a> has announced its lead neuroprotective peptide candidate ARG-007 has been granted ODD status for the treatment of HIE, which is a type of newborn brain damage caused by oxygen deprivation and limited blood flow.<\/p>\n<p>HIE may occur at any time before labour, during labour and delivery, or immediately following delivery.<\/p>\n<p>AGN says the initial injury that is caused by a loss or reduction of oxygen supply is followed by progressive brain cell death due to excitotoxicity, oxidative stress, and inflammation.<\/p>\n<p>The physiological effects resulting from the interruption to blood flow and\/or oxygen in the brain can vary greatly depending on the length of time the disruption occurs as well as its location.<\/p>\n<p>While some children may only display mild effects, others will have severe permanent disability including cerebral palsy, cognitive impairment, or developmental delay.<\/p>\n<p>\u00a0<\/p>\n<h2><strong>Great need for HIE treatment<\/strong><\/h2>\n<p>There is currently no therapeutic drug on the market to protect brain cells following cases of HIE.<\/p>\n<p>Instead, therapeutic hypothermia (cooling the body to maintain a targeted temperature) is used which can prevent or minimize permanent brain damage in some babies, however, it can result in cardiovascular and respiratory complications.<\/p>\n<p>AGN recently announced encouraging <a href=\"https:\/\/stockhead.com.au\/health\/groundbreaking-this-drug-could-be-significantly-effective-at-treating-brain-damage-in-newborns\/\">preclinical data on the potential of ARG-<\/a><a href=\"https:\/\/stockhead.com.au\/health\/groundbreaking-this-drug-could-be-significantly-effective-at-treating-brain-damage-in-newborns\/\">007<\/a> in reducing brain injury following HIE.<\/p>\n<p>The data showed ARG-007 significantly reduces brain cell death in animal models of HIE.<\/p>\n<p>The company is continuing to complete all required studies to progress into clinical trials in HIE.<\/p>\n<p>\u00a0<\/p>\n<h2><strong>FDA prioritising rare disease treatment<\/strong><\/h2>\n<p>The FDA, which is the regulatory body in the world\u2019s largest healthcare market, has been working to support development and evaluation of new treatments for rare diseases a key priority.<\/p>\n<p>The FDA has authority to grant ODD to a drug or biological product to prevent, diagnose or treat a rare disease or condition. ODD qualifies companies for incentives including:<\/p>\n<p>Tax credits for qualified clinical trials<br \/>\nExemption from user fees<br \/>\nPotential seven years of market exclusivity after approval<\/p>\n<p>AGN is developing novel therapeutics to reduce brain tissue death after stroke, other types of brain injury, and neurodegenerative diseases.<\/p>\n<p>Argenica managing director Dr Liz Dallimore says the granting of ARG-007 in HIE forms a\u00a0 key pillar of its commercialisation strategy.<\/p>\n<p>\u201cThe potential for extensive market exclusivity following approval of ARG-007 is an extremely compelling commercial driver for the company,\u201d she says.<\/p>\n<p>\u201cWe look forward to continuing to progress the development of ARG-007 as a treatment for HIE in newborn infants, in which there are currently no therapeutic drugs available to treat this devastating condition.\u201d<\/p>\n<p>\u00a0<\/p>\n\n<p><span class=\"mce_SELRES_start\">\ufeff<\/span>\u00a0<\/p>\n<p><em>This article was developed in collaboration with Argenica Therapeutics, a Stockhead advertiser at the time of publishing. <\/em><\/p>\n<p><em>\u00a0<\/em><\/p>\n<p><em>This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n<p><span class=\"et_bloom_bottom_trigger\"><\/span><\/p>\n<p>The post <a href=\"https:\/\/stockhead.com.au\/health\/us-fda-grants-argenica-orphan-drug-designation-to-treat-devastating-condition-in-newborns\/\">US FDA grants Argenica Orphan Drug designation to treat \u2018devastating condition\u2019 in newborns<\/a> appeared first on <a href=\"https:\/\/stockhead.com.au\/\">Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>US FDA grants ARG-007 orphan drug designation to treat hypoxic ischaemic encephalopathy No therapeutic drug on the market to protect brain cells following hypoxic ischaemic <a href=\"https:\/\/economicherald.net\/?p=1516\" class=\"read-more-link\">[more&#8230;]<\/a><\/p>\n","protected":false},"author":0,"featured_media":1517,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-1516","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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